What is an innovative medical device?

(1) The applicant has obtained the China patent right for the core technological invention of the product according to law through its technological innovation activities, or obtained the invention patent right or the right to use it through transferee according to law; Or the application for a patent for invention of the core technology has been made public by the patent administration department of the State Council.

(two) the main working principle/mechanism of the product is the first in China, the performance or safety of the product is fundamentally improved compared with similar products, the technology is at the international leading level, and it has significant clinical application value.

(three) the applicant has completed the preliminary research of the product and has basically finalized it, the research process is real and controllable, and the research data is complete and traceable.